STAMARIL

The Summary of Product Characteristics (SPC or SmPC) is a specific document, the wording of which has been agreed with the regulatory authority as part of the medicine approval process. It is required before any medicine is allowed on the market in Europe. It is designed to assist doctors and pharmacists in prescribing and supplying the product.

Updated on 23 March 2017 PIL

Reasons for updating

Updated on 17 January 2017 SmPC

Reasons for updating

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sanofi Pasteur MSD company name changed to Sanofi Pasteur

Updated on 16 January 2017 PIL

Reasons for updating

Company name change or merger

Updated on 3 February 2016 PIL

Reasons for updating

Change to warnings or special precautions for use

Change of contraindications

Change to side-effects

Change to information about pregnancy or lactation

Change to further information section

Change to dosage and administration

Change to improve clarity and readability

Updated on 3 February 2016 SmPC

Reasons for updating

Change to section 4.9 - Overdose

Change to section 5.1 - Pharmacodynamic properties

Change to section 5.3 - Preclinical safety data

Change to section 6.1 - List of excipients

Change to section 6.4 - Special precautions for storage

Change to section 6.5 - Nature and contents of container

Change to section 6.6 - Special precautions for disposal and other handling

Change to section 10 - Date of revision of the text

Change to section 2 - Qualitative and quantitative composition

Change to section 3 - Pharmaceutical form

Change to section 4.1 - Therapeutic indications

Change to section 4.2 - Posology and method of administration

Change to section 4.3 - Contraindications

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.6 - Pregnancy and lactation

Change to section 4.7 - Effects on ability to drive and use machines

Change to section 4.8 - Undesirable effects

Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 2: Removal of excipient with known effect 'sorbitol' to be in line with the Quality Review of Documents (QRD) template.

In section 3: Revised section with further detail: 'Before reconstitution, the powder is homogeneous, beige to orange beige, and the solvent is a limpid solution'.

In section 4.1: Includes the statement 'The validity period of this Certificate is established according to International Health Regulations (IHR) recommendations, and starts 10 days after primary vaccination and immediately after re-vaccination (see Section 4.2)'. The following has been deleted 'This certificate is valid for 10 years from the 10th day after vaccination and immediately after re-vaccination'.

In section 4.2:

Under primary vaccination it is now stated that 'The vaccine should be given at least 10 days before entering an endemic area since protective immunity may not be achieved until at least this time has elapsed'.

Paediatric population statement has been added to include – 'Children aged 9 months and older: a single dose of 0.5 ml of the reconstituted vaccine. Children under 6 months of age: STAMARIL is contraindicated in children less than 6 months of age (see Section 4.3)'.

The revaccination section has been revised to include: 'The duration of protection following administration of one single 0.5 ml dose of STAMARIL is expected to be at least 10 years and may be life-long. Re-vaccination with one dose of 0.5 ml may be needed in some individuals who had an insufficient immune response after their primary vaccination. Re-vaccination may also be required, depending on official recommendations of local Health Authorities, as a condition of entry in some countries'. The following has been deleted: 'International Health Regulations require re-vaccination, using the same dose as for primary vaccination, at intervals of 10 years in order to retain a valid certificate'.

The method of administration has been revised to state the recommended injection sites are the anterolateral aspect of the thigh in children less than 12 months of age, the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in children 12 months through 35 months of age or the deltoid muscle in children from 36 months of age onwards and adults.

In section 4.3: Myasthenia gravis has been added to the history of thymus dysfunction bullet point. Current severe febrile illness has been amended to read 'moderate or severe febrile illness or acute illness'

In section 4.4: Deletion of the sentence 'patients with rare hereditary problems of fructose intolerance should not take this vaccine'. Addition of instructions regarding syncope (fainting) and regarding procedures being in place to prevent injury from faints and manage syncopal reactions. Inclusion of sentence 'As with any vaccine, vaccination with STAMARIL may not protect 100% of vaccinated individuals'.

This statement has moved from 4.2 'DO NOT INJECT INTRAVASCULARLY. Because intramuscular injection can cause injection site haematoma, STAMARIL should not be given by the intramuscular route to persons with any bleeding disorder, such as haemophilia or thrombocytopenia, or to persons on anticoagulant therapy. The subcutaneous route of administration should be used instead'.

Addition of 'Pregnant and breast-feeding women STAMARIL should not be used in pregnant and breast-feeding woman unless when clearly needed and following an assessment of the risks and benefits (see Section 4.6)'.

Amendment of Yellow Fever Vaccine-Associated Neurotropic Disease (YEL-AND) to read as 'Very rarely, YEL-AND has been reported following vaccination, with sequelae or with fatal outcome in some cases (see Section 4.8). To date most of cases of YEL-AND have been reported in primary vaccinees with an onset within 30 days of vaccination. The risk appears to be higher in those aged over 60 years, and below 9 months of age (including infants exposed to vaccine through breastfeeding) although cases have been also reported in other age groups. Congenital or acquired immunodeficiency has also been recognized as a potential risk factor (see Section 4.3)'.

In section 4.5: Addition of 'it can induce false positive results with laboratory and/or diagnostic tests for other flavivirus related diseases such as dengue or Japanese encephalitis'.

In section 4.6: Addition of a 'fertility' section which states 'No animal fertility studies have been conducted with STAMARIL and no fertility data are available in humans'.

In section 4.8: Tabulated format to include all adverse reactions. 'Events' replaced with 'reactions'. Transient moderate leucopenia removed in Section 4.8 of the SmPC and in Section 4 of the leaflet.

Paediatric population now includes data following a clinical study performed in 393 toddlers aged 12 to 13 months which received STAMARIL and placebo concomitantly.

In addition age below 9 months (including infants exposed to vaccine through breastfeeding) has been recognized as a potential risk factor for YEL-AND.

In section 4.9 Now includes further information on cases of administration of more than the recommended dose (overdose) that have been reported with STAMARIL. When adverse reactions were reported, the information was consistent with the known safety profile of STAMARIL.

In section 5.1: Addition of 'vaccination, lasts at least 10 years and may be life-long.' Also includes 'In clinical studies in adults it has been shown that 28 days following vaccination with STAMARIL seroconversion rates of 93% and 100% were obtained'. Paediatric population data has been included and revision of ATC code from J07BL1 to J07BL01, 'In a clinical study conducted in 337 toddlers aged 12 to 13 months the yellow fever seropositivity rates 28 days post injection of STAMARIL were 99.7% (98.5; 100.0) and the Geometric Mean Titers were 423 (375; 478). In another clinical study conducted in 30 children and adolescents aged 2 to 17 years a seroconversion rate of 90 to 100% was observed confirming results observed in earlier clinical studies'.

In section 5.3: Amended statement to No non-clinical studies have been performed.